臨床研究等提出・公開システム

Date of registration	Mar. 01, 2021
Last modified on	July. 05, 2022
Trial ID	jRCT2051200141

Scientific Title	Efficacy and safety of FPF300 for epistaxis in Hereditary Hemorrhagic Telangiectasia(HHT) : A Phase IIa Study
Public Title	A Phase IIa Study of FPF300

Contact for Scientific Queries	Name	Tochikawa Yoshinaga
	Affiliation	Fujimoto Pharmaceutical Corp.
	Address	1-3-40 Nishiotsuka, Matsubara, Osaka
	Telephone	+81-72-332-5151
	E-mail	y-tochikawa@fujimoto-pharm.jp
Contact for Public Queries	Name	Tochikawa Yoshinaga
	Affiliation	Fujimoto Pharmaceutical Corp.
	Address	1-3-40 Nishiotsuka, Matsubara, Osaka
	Telephone	+81-72-332-5151
	E-mail	y-tochikawa@fujimoto-pharm.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 01, 2021
Actual date of first enrollment		Mar. 24, 2021
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who have diagnosed as definite HHT by the Curacao criteria 2) Patients who have exceeded 4 points by Epistaxis Severity Score and have epistaxis at least three times a week on average since 4weeks before patient's consent 3) Patients whose age are 20 or older at the time of their consent 4) Patients who adhere to FPF300 risk management system
	Exclusion Criteria	1) Women in pregnancy, breastfeeding or child bearing Men who wish their partners to become pregnant during the study period 2) Patients who have previously been prescribed the following agents a) thalidomide and derivatives (lenalidomide and pomalidomide) b) angiogenesis inhibitors (e.g. bevacizumab, pazopanib) 3) Patients who have the medical history(except for a)) or complications below a) anemia by reason of other than HHT b) hemorrhagic disease (e.g. hemophilia) by reason of other than HHT c) pulmonary embolism / deep vein thrombosis d) bradycardic arrhythmia e) heart failure f) pulmonary hypertension g) active cancer within 5 years of disease free interval 4) BNP >= 100 pg/mL or NT-pro BNP >= 400 pg/mL 5) Patients who have a high risk of deep vein thrombosis 6) Patients who are positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Recurrent epistaxis in Hereditary Hemorrhagic Telangiectasia
Intervention(s)		FPF300 is orally administered once daily. The initial daily doses will be started at 25 mg and adjusted the dose depending on the patient's condition.
Primary Outcome(s)		Improvement rate of Epistaxis Severity Score
Secondary Outcome(s)		Safety etc.

Primary Sponsor	Fujimoto Pharmaceutical Corp.

Name of Certified Review Board	Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital Funded research Review Committee
Address	2-13-22 Miyakojimahondori Osaka Shi Miyakojima Ku, Osaka
Telephone	+81-6-6929-1221
Approval Status	Approval
Date of approval	Feb. 22, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 05, 2022	(this page)	Changes
4	June. 14, 2021	Detail	Changes
3	April. 09, 2021	Detail	Changes
2	Mar. 10, 2021	Detail	Changes
1	Mar. 01, 2021	Detail

List of change history